Orchestra Pregnancy Observational Study in Poland

Status Completed

Clinical Trial Summary

The aim of this project is to document the use of insulin pump therapy (CSII), including sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1 Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time and Paradigm Veo pumps in Poland.

Clinical Trial Description

The project is designed as a multi-center prospective observational Post-Market-Release study to be conducted in up to 30 centers in Poland.

Total duration of the study per patient will be up to 22 months (up to 12 months pre-conception phase, pregnancy, and 6 weeks after delivery). The optimal study start is the beginning of pre-conception phase, however, pregnant women up to the 16th week of pregnancy can participate in the study too. The study end is 6 weeks after delivery. If conception does not occur within 12-months, the patient's study participation is terminated, and the insulin pump might be taken away from the patient. The following therapy is decided by the investigator. If the pump is not taken away after the 12-month of trial period for conception, the patient can continue insulin pump therapy until the pump is needed for another patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01779141
Study type	Observational [Patient Registry]
Source	Medtronic Diabetes
Contact
Status	Completed
Phase
Start date	May 2013
Completion date	August 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03442582` - Afluria Pregnancy Registry
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Enrolling by invitation	`NCT05415371` - Persistent Poverty Counties Pregnant Women With Medicaid	N/A
Completed	`NCT04548102` - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman	N/A
Completed	`NCT03218956` - Protein Requirement During Lactation	N/A
Completed	`NCT02191605` - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy	N/A
Completed	`NCT02223637` - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting	`NCT06049953` - Maternal And Infant Antipsychotic Study
Completed	`NCT02577536` - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting	`NCT06336434` - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy	Phase 1/Phase 2
Not yet recruiting	`NCT05412238` - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months	N/A
Not yet recruiting	`NCT04786587` - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting	`NCT05028387` - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed	`NCT02783170` - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women	Phase 4
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1
Recruiting	`NCT02564250` - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women	N/A
Recruiting	`NCT02619188` - Nutritional Markers in Normal and Hyperemesis Pregnancies	N/A
Recruiting	`NCT02507180` - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Completed	`NCT02408315` - Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)	Phase 3